Noted This Week

August 39

The FDA approved the anti-CCR4
monoclonal antibody mogamulizumab-kpkc (Poteligeo; Kyowa Hakko Kirin) for
the treatment of relapsed/refractory mycosis fungoides or Sézary syndrome, two
rare forms of non-Hodgkin lymphoma. The approval was based on a phase III trial
in which patients treated with the drug had a median progression-free survival
of 7.6 months, compared with 3.1 months in patients who received chemotherapy.

The FDA warned that azithromycin
may increase the risk of relapse and death in certain patients with blood or
lymph node cancers. The agency recommends against prescribing the
antibiotic long-term to treat bronchiolitis obliterans syndrome in patients
with these cancers who undergo an allogenic stem cell transplant. In the phase
III ALLOZITHRO trial, patients treated with the antibiotic had a relapse rate
of 32.9% and a 2-year survival rate of 56.6%, compared with 20.8% and 70.1%,
respectively, in patients who received a placebo.

Certain germline mutations may
increase the risk of triple-negative breast cancer, according to a study in the Journal of the
National Cancer Institute. Researchers analyzed genomic data from 10,901
women with the disease and found that BARD1, BRCA1, BRCA2,
PALB2, and RAD51D mutations were associated with high risk of
triple-negative breast cancer in Caucasian women, and BRIP1, RAD51C,
and TP53 alterations were linked to moderate risk. Overall, 12% of
participants had a pathogenic variant in one of these genes.

Regeneron Pharmaceuticals and bluebird bio teamed up to develop CAR T-cell
therapies, with Regeneron investing $100 million in bluebird. The companies
have chosen six initial drug candidates—per the 5-year deal, they will split
research costs until a drug reaches clinical trials, at which point Regeneron can
opt in 50/50 to continue developing it.

MUC16 mutations
may be a useful biomarker for gastric cancer, according to just-published research
findings. Researchers
analyzed 437 gastric cancer samples from The Cancer Genome Atlas and 256
samples from a cohort of Asian patients and found that MUC16 mutations
occurred in 38% of samples from the former and 22% of samples from the latter.
The alterations were associated with a significantly greater tumor mutational
burden and longer median overall survival (OS).

Broad-based genomic sequencing
may not benefit patients with advanced non–small cell lung cancer. In a
retrospective study,
only 4.5% of patients whose tumors were sequenced received targeted treatment
based on the results. Further, sequencing was not associated with an
improvement in 12-month mortality or OS compared with patients who had routine
testing limited to EGFR and/or ALK mutations.